Trials / Terminated
TerminatedNCT03572478
Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer
A Phase Ib/IIa Study of Rucaparib (PARP Inhibitor) Combined With Nivolumab in Metastatic Castrate - Resistant Prostate Cancer and Advanced/Recurrent Endometrial Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 1/phase 2a study of the combination of immune checkpoint inhibitor (nivolumab) in combination with the PARP inhibitor (rucaparib) for patients with metastatic castration resistant prostate cancer (mCRPC) and metastatic/recurrent endometrial cancer. In the phase 1 portion, the safety of the combination dosing will be determined. If the combination dosing is determined to be safe and feasible, the study will move onto phase 2a. In the phase 2a portion, participants will be randomized to receive either: rucaparib alone, nivolumab alone, or combination therapy (rucaparib and nivolumab).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rucaparib | 600 mg taken by mouth twice daily. |
| DRUG | Nivolumab | 480 mg given by intravenous (IV) infusion every 4 weeks. |
Timeline
- Start date
- 2018-08-14
- Primary completion
- 2020-02-29
- Completion
- 2020-10-01
- First posted
- 2018-06-28
- Last updated
- 2021-03-09
- Results posted
- 2021-02-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03572478. Inclusion in this directory is not an endorsement.